1. (Date of presentation) (Name of presenter) UK IBD audit Biological therapies audit 2014 Comparison of (Your site name) results against the national results for the clinical audit of biological therapies

2. Participation Sites are eligible if they give biological therapy to IBD patients. There are 163 adult trusts / health boards eligible to participate in round 4 of the UK IBD audit 150/163 (92%) are participating in the biologics audit and/or in the Personalised Anti‐TNF Therapy in Crohn’s disease (PANTS) research study. On 28 February 2014, details of 6,458 patients had been entered. Only those cases that are locked on the web tool are able to be included in national analyses

3. Key results Summary of adult patients included in national analysis CDYour siteUCIBDUTotal Patients a 2715??467903272 Initial treatments2813??477983388 IFX1363??420631846 ADA1450??57351542 Follow up treatments5147??8282166191 IFX3302??7601504212 ADA1845??68661979 All treatments total7960??13053149579 a 98 patients with CD / 10 with UC / 8 with IBDU were treated with both IFX and ADA

4. Key results Summary highlighting key data items for CD CD – Adult % (n/N) Your site Percentage of all patients that were classified as having CD (of all patients with CD, UC or IBDU included) 83% (2715/3272)?? General patient characteristics Gender: Male47% (1282/2715)?? Age at diagnosis, median (IQR) a (N=2549) 26 (19, 37) ?? Age at initial treatment, median (IQR) a (N=2549) 35 (25, 48) ?? Time from diagnosis to treatment in years, median (IQR) b (N=2553) 5.23 (1.55, 12.21) ?? a Denominators change to exclude cases where date / disease severity score was not provided b Where a patient switched treatment, the first treatment the patient received was used

5. Key results Summary highlighting key data items for CD continued CD – Adult % (n/N) Your site Disease distribution (162 adult patients had no IBD disease details recorded) Terminal ileum (L1)25% (644/2553)?? Colonic (L2)35% (884/2553)?? Ileocolonic (L3)32% (806/2553)?? None of these9% (219/2553)?? Any part of the gut proximal to the terminal ileum (L4) Yes50% (1165/2308)?? Perianal involvement Yes33% (643/1955)??

6. Key results Summary highlighting key data items for CD continued CD – Adult % (n/N) Your site Pre-treatment surgery recorded a Yes30% (822/2715)?? Response to treatment and remission (at any follow‐up between 10 and 14 weeks) a Response to treatment (adult patients – HBI drop of >3) 87% (195/224)?? Remission achieved (adult patients – HBI score of <4) 70% (170/244)?? Adverse events (at any follow up treatment) Number of adverse events reported4% (224/5092)?? Number of patients that experienced at least one adverse event 11% (180/1667)?? a Denominators change to exclude cases where date / disease severity score was not provided

7. Key results Audit objective: appropriateness of prescribing anti-TNFα CD adult compliance with a selected TA187 NICE criterion National CD data % (n/N) Your site Criterion 1.1 severe active CD and not responded to conventional therapy, or be intolerant of or have contraindications to conventional therapy Patients with HBI score of >8 prior to commencing anti‐TNFα 58% (592/1028)?? Patients who were treated with conventional therapy 82% (2237/2715)?? Appropriate prescription in compliance with NICE criterion 1.1 (TA187) 54% (552/1028)??

8. Key findings Participation was encouraging at 92%. It is likely that a minority of cases were entered at some sites. Indication for treatment: Refractory luminal Crohn’s disease (77% Infliximab / 87% Adalimumab) Severe perianal Crohn’s disease (19% Infliximab / 9% Adalimumab) Refractory UC and indeterminate colitis are less common indications for treatment. 23% of CD patients are given a lower dose (80/40 mg) induction regime for adalimumab. 2% of patients with CD are on higher-dose infliximab (10 mg/kg) and 4% of patients are on higher-dose adalimumab (80 mg) at follow-up In 53% of CD patients the prescription adhered to NICE TA187 criterion 1.1. 22% of patients with CD are on steroids at initial treatment, this had dropped to 8% at follow-up.

9. Key findings continued 8% of patients with CD had discontinued treatment by follow- up. In only 11% of these patients was the treatment effective and discontinued. Recorded adverse events are uncommon. Acute treatment reactions and infections are the commonest events recorded. Malignancy was reported in 4/2028 patients (0.2%) For patients with CD, treatment with a biologic resulted in response rate of 87% remission in 70% of patients.

10. National recommendations / action plan National recommendationsAction requiredStaff responsibleProgress at your site 1.Sites should continue to participate in the national biological therapy audit and aim to submit data on all appropriate patients. Data can also be entered by taking part in the Personalised Anti-TNF Therapy in Crohn’s disease study (PANTS). Data entered in the study will be analysed and included in the next national report, to be published next year. Eligible sites should participate in either the biological therapy audit or the PANTS research study and submit data on all newly started patients on biologics. Where possible, collaborate with other sites that have a well-established methodology for capturing data on new patients starting on biological therapies Consultant gastroenterologists IBD nurses Infusion clinic staff 2.160/80 mg of adalimumab should be used for induction therapy. Ensure that the appropriate starting dose is in local protocols Consultant gastroenterologists IBD nurses 3.Clinicians should consider stopping 5-aminosalicylic acid (5- ASA) drugs in patients on biologics with Crohn’s disease. Steroids should be weaned and stopped where possible. Review concomitant medication of patients on biologics. Consider stopping 5-ASA Consultant gastroenterologists IBD nurses

11. National recommendations / action plan National recommendationsAction requiredStaff responsibleProgress at your site 4.Sites should routinely assess disease activity at baseline and again at 3- and 12-month follow- up; this measure forms an important part of objective assessment of response to treatment and the quality of care provided by the IBD service. Ensure that a mechanism is in place to allow the collection of disease activity scores at baseline and follow-up Consultant gastroenterologists IBD nurses Infusion clinic staff 5.Local teams should encourage patients to complete patient- reported outcome measures (EQ- 5D and CCQ12) at baseline and again at 3- and 12-month follow- up; this measure also forms an important part of objective assessment of response to treatment and the quality of care provided by the IBD service. Ensure that a mechanism is in place to allow the collection of quality of life scores at baseline and follow-up. Copies of the scores can be downloaded from the web tool (www.ibdbiologicsaudit. org/)www.ibdbiologicsaudit. org/ Consultant gastroenterologists IBD nurses Infusion clinic staff 6.Sites participating in the audit should export their own local data and use them for local analyses, benchmarking and quality improvement activities. Identify an appropriate time to discuss results and decide priority areas for improvement NHS managers Consultant gastroenterologists IBD nurses

12. National recommendations / action plan National recommendationsAction requiredStaff responsibleProgress at your site 7.The findings and recommendations of this report should be shared at relevant multidisciplinary and clinical governance / audit meetings, and local action plans for implementing change should be devised. Identify an individual to present the findings at an appropriate meeting. Ensure that this activity has been planned and, when planned, that there is capacity in the meeting to review where changes are required and that action plans for implementing changes are devised NHS managers All members of the IBD team 11.ENTER THE LOCAL ACTIONS YOU HAVE IDENTIFIED HERE 12.ENTER THE LOCAL ACTIONS YOU HAVE IDENTIFIED HERE

13. Thank you for your continued effort in supporting the work of the UK IBD audit Your feedback and views are very important to us, please give us your thoughts: Tel: 020 3075 1566 Email:biologics.audit@rcplondon.ac.ukbiologics.audit@rcplondon.ac.uk